Silicone Gel-Filled Breast Implants

These implants have recently been approved for more general use by the FDA. They are available for individuals 22 years of age or older who have had an opportunity to carefully consider augmentation with saline filled or silicone gel implants, have studied the informational brochure and have committed to the long range study of these implants.

If you have an interest in proceeding please study this material; and call for consultation at +1-828-210-9324.

The three types of silicone gel-filled breast implants are as follows:

  • One type is a single lumen implant that is prefilled by the manufacturer with a fixed volume of silicone gel.
  • A second type is a double lumen implant with (1) an inner lumen prefilled by the manufacturer with a fixed volume of silicone gel and (2) an outer lumen that is filled during the operation with a fixed volume of saline through a valve.
  • A third type is a double lumen implant with (1) an outer lumen prefilled by the manufacturer with a fixed volume of silicone gel and (2) an inner lumen that is filled during the operation with saline through a valve. This type of implant allows for adjustments of the saline volume after the operation.
  • A silicone gel-filled breast implant has a silicone rubber shell with the same general composition as noted under the heading Saline filler breast implants.

The filler is silicone gel that has the general composition of:

  • Silicone oil
  • Cured polymeric (large) silicones
  • Small amounts of uncured large and smaller silicones
  • Minute amounts (parts per million) of metals, including a metal catalyst (usually platinum). (A catalyst is something that causes a change in material.)

Information to Help You Decide

The silicone gel implants that have been approved for use are manufactured by two companies: Mentor and INAMED (a subsidiary of Allergan). While the materials and processes are quite similar they are not identical. Material from both companies are presented and are available.

Please review this material and actively participate in the educational tools provided.

Silicone gel-filled breast implant. Silicone gel-filled breast implant. Silicone gel-filled breast implant.

This cohesive gel implant has been lacerated so that you can see the gel inside.

 

What is the Mentor Adjunct Study?

The Mentor Adjunct Study is an ongoing research study for breast reconstruction patients in the U.S. who are eligible to receive silicone gel-filled breast implants. Silicone gel-filled implants are considered investigational devices and are only available through an approved study. The study was established in 1992 through an agreement between Mentor and the U.S. Food and Drug Administration (FDA). Mentor was the first company for which the FDA authorized such a study.

The study's main objective is to satisfy the public health need for providing women who have had a mastectomy with breast reconstruction devices. Another study objective is to gather safety data about short-term complications women may experience after they have had breast reconstruction surgery with Mentor silicone gel-filled implants.

The safety information collected during this study will provide Mentor with valuable information that will help the FDA assess the potential risks and complications for patients who undergo breast reconstruction surgery with silicone gel-filled breast implants.

The Adjunct Study is an ongoing study involving all eligible breast reconstruction patients in the U.S. who receive Mentor silicone gel-filled breast implants. Also eligible for this study are patients with severe congenital deformities, such as pectus excavatum and pectus carinatum, or patients with severe ptosis who underwent mastopexy with associated replacement. Patients requiring revision of saline- or gel-filled implants who are not suitable for revision with saline implants may qualify if they have specific medical justification, as outlined in the clinical protocol, from their physician. Subjects are followed for five years following implantation and are seen at least three times during this period.